EEG Characteristics in Youth POTS and/or Syncope

NCT02167412 | Completed

• 1 other identifier: IRB14-00252
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Orthostatic intolerance refers to symptoms that occur with standing and improve or resolve with recumbency. Few studies have evaluated orthostatic intolerance symptoms by electroencephalography (EEG), and none of those studies have focused on the adolescent-aged patient. This study will compare EEG characteristics and sweat rate during head-upright tilt (HUT) testing among patients with postural tachycardia syndrome (POTS) and patients with syncope without POTS. Patients with POTS will also undergo a separate HUT with abdominal and lower extremity compression. The primary aim of this study is to characterize video EEG changes that correspond with orthostatic intolerance in youth during HUT testing. The investigators hypothesize that the clinical encephalopathy related to POTS and referred to as 'brain fog' will have an electrographic correlate. Secondary aims include (1) EEG comparisons of POTS symptoms with and without abdominal and lower extremity compression during HUT, (2) correlation between sweat rate and EEG changes during HUT, and (3) analysis of EEG characteristics that distinguish syncope with POTS from syncope without POTS. The investigators hypothesize that POTS patients have prolonged syncopal prodromes (compared to syncope patients without POTS) which are protective of syncope during daily activities.

Conditions

Syncope; Postural Tachycardia Syndrome; Orthostatic Intolerance

Keywords

POTS; Syncope

Outcome Measures

Primary Outcomes (1)

• Video EEG characteristics of POTS and syncope

  Video EEG characteristics of orthostatic intolerance symptoms related to POTS (with and without syncope) and to syncope (without POTS) will be identified and compared between POTS and syncope cohorts.

  The time frame on average is 90 minutes and will not exceed 3 hours.

Secondary Outcomes (3)

• EEG characteristics of POTS with and without compression

  The time frame on average is 90 minutes and will not exceed 3 hours.

• EEG comparison of syncopal prodrome with and without POTS

  The time frame on average is 90 minutes and will not exceed 3 hours.

• Correlation between sweat rate and EEG changes

  The time frame on average is 90 minutes and will not exceed 3 hours.

Study Arms (1)

Syncope without POTS

Patients meeting syncope criteria without POTS. There will be no intervention for this study arm.

Eligibility Criteria

• Age: 9 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the neurology-based POTS and Syncope clinic at Nationwide Children's Hospital (Columbus, OH) with POTS or with syncope without POTS and meeting eligibility criteria will be asked to participate.

You may qualify if:

• Patients aged 9-21 years
• Referred to the neurology POTS and Syncope clinic at Nationwide Children's Hospital for clinical tilt table testing
• Has prior diagnosis or signs/symptoms of POTS (with or without syncope) or syncope (without POTS)

You may not qualify if:

• Cognitive, somatic or psychiatric illness that precludes tilt table testing, prolonged standing, or EEG lead placement
• Known seizure disorder
• Scalp or skull defect that could affect EEG amplitudes
• Pregnancy
• Non-English speaking

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hopsital

Columbus, Ohio, 43205, United States

Location

Related Links

• Nationwide Children's Hospital POTS and Syncope clinic

MeSH Terms

Conditions

Syncope; Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Officials

• Geoffrey L Heyer, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 19, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

US (1)